Viatris
o many casual observers, pharmacovigilance (PV) and medical writing (MW) can appear as two disconnected pieces in the drug development lifecycle. In many organizations, PV and MW are two different functions, working in two different silos. Different terminology between these two fields doesn’t do much to correct this perception.
Navigating Synergy between Both Worlds
For ease of thought navigation, we can think of PV (or drug safety) as having two key components: safety reporting (ICSRs and aggregate reports) and safety monitoring (or safety surveillance). Medical writing is intimately related in developing the content of the documents that define, direct, and support these activities.
The pre-marketing and post-marketing phases of this lifecycle feature numerous documents authored by medical writers which address several safety-related topics. Often considered “safety writing” (the common ground of drug safety and medical writing), in the pre-marketing phase these documents include:
- Development Safety Update Report
- Risk Management Plan
- 120-Day Safety Update
- Safety Surveillance plans
- Ad hoc safety review document
- Responses to health authority questions
- Special safety white papers/literature safety reviews.
In the post-marketing phase, the most common documents are the Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Pediatric Adverse Event Reports (PAER), and risk management plans.
Some may suggest that the purview of core regulatory medical writing is slightly different and is more often than not associated with successful drug submissions. Study protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), and the Common Technical Document (CTD) are among these typical, core regulatory medical writing documents. However, close examination of these documents reveals their interdependence and correlation with PV and drug safety. For example, IBs serve as reference safety information upon which safety surveillance plans are built. Narratives based on safety events comprise a large portion of the CSR, and important CTD modules (i.e., 2.7.4, summary of clinical safety) address drug safety.
Looking through the Business Lens
This growth in both domains (MW and PV) can be primarily attributed to the rise in outsourcing and R&D investment.
India is among the leading countries as a source of Contract Research Organizations (CROs) that cater to the MW and PV needs of pharmaceutical companies. Cost is one reason, but the availability of trained, qualified professional resources delivering efficient outcomes has proven just as important.
Forward into the Future
Bringing PV and MW together under the same organizational structure, under the same leadership, helps communicate the “big-picture message” that patient safety is of utmost importance for a sponsor.
In such a structure, establishing synergy between the domains becomes easier. Access to a missing source document needed to write a safety report becomes quicker, and writers can quickly check their understanding of safety by consulting the medical resources in the PV department. Narratives can come together more efficiently when these teams can work together. In my personal experience, this model works to effectively bridge the gaps between the workflows of both domains and delivers better outcomes for all.
For example: If safety professionals learn how the data from the ICSRs which are entered into the study database ultimately translate into the narrative that can ensure the safety of a patient either in a clinical trial or as a consumer, their job not only becomes more meaningful, but it may also improve the quality of their work.
As professionals and as organizations working in drug development, our aim remains the same: to ensure patient safety, whether that drug is in development or on the market. We work toward this aim in a multitude of ways: by making sure our studies are designed for patient safety; properly documenting all possible adverse reactions; understanding and documenting the benefits and risks inherent in that drug; and continuing this cycle of monitoring and documentation throughout the drug lifecycle. Reaching this aim is possible if we synergize the two different yet closely related domains of medical writing and pharmacovigilance.